To strategically plan the filings for US/EU and plan for the resources to meet the defined timelines for submissions.

To liaise with the Regulatory Authorities for submissions, query responses etc.

To co-ordinate with various functions within R &D and manufacturing locations for data generation for submissions and provide regulatory guidance

To ensure quality dossier preparation/ submissions for the regulated markets (US/EU) as per timelines.

To provide support for the Regulatory Authority Audits to the manufacturing locations.

Job Specification: Project Management

Designation: Executive / Sr. Executive

Qualification: B.Pharm / M.Pharm

Experience: 3-6 years

Desired Profile:

Product development through the entire product cycle from strategic and tactical perspectives

A well-developed understanding of the generic pharmaceutical development process acquired through a minimum of 3-6 years of industry experience in at least one of the following areas: drug formulation development, clinical strategy development, or project management.

Must have the ability to work with external vendors such as CROs, CMOs, consultants, material vendors and other external third parties to drive a strong development program.

Needs to have a strong understanding of the US generic pharmaceutical industry and additionally possess understanding other major global markets as applies to the generic pharmaceuticals.

Job Specification: Packaging & Development (R&D)

Designation: Executive/ Sr. Executive

Qualification: M.Sc / B. Pharma / M.Pharma / PG Diploma in Packaging

Experience: 5 8 Years

Desired Profile:

Packaging Development of Injectable / Ophthalmic for Regulatory market.

Dose devices, Compliance pack for both products

Packaging development of both dosages with respect to Quality by design.

Primary, Secondary and Tertiary packaging development of both dosages forms

Preparation of STP and Spec for packaging materials and performing test to evaluate the Packaging materials.

Identification & determination of suitable packaging change part, packaging components as well as development of new product art work, bill of material, batch packaging record.

To solve the packaging related problem suggested by marketing or production.

Development of moulds & trials for packaging material.

Designing Skills:

AUTOCAD

Job Specification: Manufacturing Injectable

Designation: Executive / Sr. Executive

Qualification: B.Pharm / M.Pharm

Experience: 3 6 Years

Desired Profile:

To observe & follow practices as per standard operating procedures of the production department

To be aware and responsible for achieving quality objective and fulfilling the requirements of the quality of the companys service by means of applicable quality procedures as per cGMP.

To manufacture and fill the batch in accordance with laid down quality standards.

Completion of all the records related to production area.

To perform and ensure that required in process tests are performed as per requirement and set standards.

Please note, preference will be given to those who are having experience in USFDA regulated plant.

We Amneal Pharmaceuticals Co. (I) Pvt. Ltd. represent a new generation of generics. Amneal Pharmaceuticals, L.L.C. has grown from a small OTC contract manufacturer to a high-quality producer of both solid and liquid generic prescription pharmaceutical products. Through strategic partnerships, focused acquisitions, and innovative R&D, we are swiftly progressing toward our objective of becoming one of the nation's top-10 generic pharmaceutical companies. Our company started in Paterson, New Jersey and remains headquartered there today with new facilities sprouting up all over the globe. We now operate in Glasgow, Kentucky; Branchburg and Fairfield, New Jersey; Ahmadabad, Gujarat, India; and Long Island, New York. Amneal continues to manufacture all of our own products in the United States under the strictest of guidelines.